A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Of The Efficacy And Safety Of The Rotigotine Transdermal Patch In Chinese Subjects With Early-stage Idiopathic Parkinson's Disease

Change in the sum of the score from the Activities of Daily Living (ADL) scale and motor examination in the Unified Parkinson's Disease Rating Scale (UPDRS) (Parts II+III, a UPDRS subtotal) from Baseline to the end of Double-blind Maintenance Period [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 24) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response to therapy, defined as ≥20 % decrease in the sum of scores from Activities of Daily Living (ADL) & motor examination in Unified Parkinson's Disease Rating Scale (UPDRS Parts II+III, a UPDRS subtotal) from Baseline to end of Maintenance Period [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 24) ] [ Designated as safety issue: No ]

Change in Unified Parkinson's Disease Rating Scale [UPDRS Part II (ADL)] from Baseline to the end of the Double-blind Maintenance Period [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 24) ] [ Designated as safety issue: No ]

Change in Unified Parkinson's Disease Rating Scale [UPDRS Part III (motor examination)] from Baseline to the end of the Double-blind Maintenance Period [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 24) ] [ Designated as safety issue: No ]

The study includes a maximum 4-week Screening Period, a maximum 4-week Titration Period for early-stage Parkinson's disease 24-week Maintenance Period, a maximum 6-day De-escalation Period and 30-day Safety Follow-Up Period. The maximum study durations for an individual subject with early-stage Parkinson's disease will be 36 weeks.

Eligibility

Ages Eligible for Study:

30 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

An Independent Ethics Committee (IEC)-approved written informed consent is signed and dated by the subject or by the legal representative

Subject/legal representative is considered reliable and capable of adhering to the protocol, visit schedule or study medication intake according to the judgment of the investigator

Subject has Idiopathic Parkinson's Disease of ≤5 years' duration, defined by the cardinal sign, Bradykinesia, plus the presence of at least 1 of the following: resting tremor, rigidity, or impairment of postural reflexes, and without any other known or suspected cause of Parkinsonism

If the subject is receiving an Anticholinergic agent (eg, Benztropine, Trihexyphenidyl, Parsitan, Procyclidine, Biperiden), a monoamine oxidase (MAO)-B inhibitor (eg, Selegiline), an N-methyl-d-aspartate (NMDA) antagonist (eg, Amantadine), he/she must have been on a stable dose for at least 28 days prior to Baseline (Visit 2) and be maintained on that dose for the duration of the study

Exclusion Criteria:

Subject has previously participated in this study or subject has previously received the study medication under investigation in this study

Subject is participating in another study of an investigational drug or has done so within 28 days prior to the Baseline Visit (Visit 2)

Subject has a history of significant skin hypersensitivity to adhesive or other transdermal preparations or recent unresolved contact Dermatitis

Subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening (Visit 1)

Subject has a history of Pallidotomy, Thalamotomy, deep brain stimulation, or fetal tissue transplant

Subject has dementia, active psychosis or hallucinations, or severe depression

Subject is receiving therapy with a dopamine agonist either concurrently or has done so within 28 days prior to the Baseline Visit (Visit 2)

Subject is receiving therapy with L dopa/carbidopa and/or L-dopa/benserazide within 28 days of Baseline (Visit 2) or has received L-dopa/carbidopa and/or L-dopa/benserazide for more than 6 months since diagnosis

Subject is currently receiving central nervous system (CNS) active therapy (eg, sedatives, hypnotics, antidepressants, anxiolytics), unless the dose has been stable for at least 28 days prior to Baseline Visit (Visit 2) and is likely to remain stable for the duration of the study

Subject has a current diagnosis of Epilepsy, has a history of seizures as an adult, has a history of stroke, or has had a transient ischemic attack within 1 year prior to Screening (Visit 1)

Subject has clinically relevant hepatic dysfunction (as defined as a total bilirubin >2.0 mg/dL or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than 2 times the upper limit of the reference range)

Subject has clinically relevant cardiac dysfunction (any cardiac disorder which in the opinion of the investigator would put the subject at risk of clinically relevant arrhythmia) and/or myocardial infarction within the last 12 months

Subject has a QT interval corrected for heart rate according to Bazett's formula (QTcB) of ≥500 ms at Screening (Visit 1)

Subject has a history of only symptomatic (not asymptomatic) orthostatic hypotension with a decrease of systolic blood pressure (SBP) from supine to standing position of ≥20 mmHg or of ≥10 mmHg in diastolic blood pressure (DBP) after 1 or 3 minutes within 28 days prior to the Baseline Visit (Visit 2), or SBP less than 105 mmHg at study entry

Subject has evidence of an impulse control disorder (ICD) at Screening (Visit 1)

Subject has a history of known intolerance/hypersensitivity to the following Antiemetics; Domperidone, Trimethobenzamide, Ondansetron, Tropisetron, Granisetron, and Glycopyrrolate

Subject has a history of chronic alcohol or drug abuse within the last 5 years

Subject is pregnant or nursing, or is of childbearing potential but (i) not surgically sterile or (ii) not using adequate birth control methods (including at least a double barrier method) or (iii) not sexually abstinent or (iv) not at least 2 years post-menopausal

Subject has any other clinically relevant medical condition, psychiatric condition, or laboratory abnormality, which would in the judgment of the investigator, interfere with the subject's ability to participate in the study

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01646268